Why it was recalled
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Product description
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.
Lot numbers, UPCs & expiration codes
Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
Where it was sold
US: Nationwide Including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0781-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 5, 2016
- FDA report date
- Mar 30, 2016
- Quantity
- 148,331 Inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AstraZeneca Pharmaceuticals LP
Original FDA data
Every field from FDA enforcement report D-0781-2016, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 73538
- Address
- 1800 Concord Pike, P.O. Box 15437
- Address (line 2)
- Health Services Medical FOC 1
- Code information
- Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
- Postal code
- 19850-5437
- Report date
- Mar 30, 2016
- Product type
- Drugs
- Recall number
- D-0781-2016
- Classification
- Class II
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- Product quantity
- 148,331 Inhalers
- Termination date
- Jun 20, 2017
- Reason for recall
- Defective Delivery System: Some units have actuation counters set to a number other than 60.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.
- Distribution pattern
- US: Nationwide Including Puerto Rico
- Recall initiation date
- Feb 5, 2016
- Center classification date
- Mar 22, 2016